Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210
FDA Recall Z-0127-2007 · Posted 2006-11-02
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2006-09-27
Date Terminated2009-08-12
Product Quantity830 units
Reason for Recall
Biological indicator failed. Investigation eliminated all equipment and product related factors.
Firm Action
Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Root Cause
Other
Distribution Pattern
Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.